Prescription drug · ANDA
etodolac NDC 83980-031
Etodolac 200 mg/1 · Capsule · Oral · Ipca Laboratories Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83980-031-01 | 83980003101 | 100 CAPSULE in 1 BOTTLE (83980-031-01)Marketed from Feb 6, 2026 | |
| 83980-031-05 | 83980003105 | 500 CAPSULE in 1 BOTTLE (83980-031-05)Marketed from Feb 6, 2026 | |
| 83980-031-13 | 83980003113 | 30 CAPSULE in 1 BOTTLE (83980-031-13)Marketed from Feb 6, 2026 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- etodolac
- Generic name (nonproprietary)
- etodolac
- Active ingredients
- Etodolac — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Ipca Laboratories Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205448
- Marketing start
- Listing expires
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)
- Identifiers
- Product ID 83980-031_fa34700b-9acd-4ccf-9e98-0f88e4a35e12SPL ID fa34700b-9acd-4ccf-9e98-0f88e4a35e12SPL set ID d583988c-3e7e-4415-b2fd-34049791cd1cRxCUI 197684, 197685UNII 2M36281008
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483980003101followed by a unit qualifier and the quantityPackage 83980-0031-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac capsules and other treatment options before deciding to use etodolac capsules. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac capsules are indicated: • For acute and long-term use in the management of signs and symptoms of the following: 1. Osteoarthritis 2. Rheumatoid arthritis • For the management of acute pain
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 205448
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.